tecurat GmbH – Well advised right from the start
tecurat GmbH gives you a first enlightening insight into the seemingly endless expanses of laws & standards around the development & approval of medical devices.
Right from the start, we familiarize you with the requirements necessary to consider for the development of your medical device. – So that you don't waste unnecessary resources.
In addition to knowledge transfer, we actively support you in assuming your responsibility as a manufacturer and complementing your team in important roles until your crew is complete.
Do you take the EU-MDR as the only valid set of rules for obtaining a CE mark?
Your development is already in full motion but the requirements of your stakeholders have not yet been defined?
Your team has not yet reached the scope & expertise to cover all required roles company internal?
Do these thoughts sound familiar? Then contact us to get answers to your open questions and Make an appointment with us!
Innovation as a beacon of hope
The enthusiasm to develop a medical device that is seen as a beacon of hope for a certain patient population is usually slowed down when confronted with the standards of the medical device industry for the first time.
Legal hurdle
The impression quickly arises that laws & standards are sheer harassment of manufacturers and lack a real benefit.
tecurat GmbH has set itself the goal of taking on the horrors of start-ups in the medical device industry and making the meaningfulness of the regulations plausible by an easily understandable and pragmatic demonstration of the respective requirements.
Safety & Performance – the main characters
However, if you look at a product from the patient’s point of view – whose role you could all too quickly assume yourself – it becomes apparent that process monitoring is indispensable with respect to safety & performance. Furthermore, the aspects of quality & documentation take on a different status in the internal chain of argumentation before the MDR instigating implant scandal.
Medical Device Life Cycle
Our training courses on normative requirements are designed to familiarize you with your obligations as a manufacturer in an easily un-derstandable way. In doing so, we consider the entire life cycle of your product with the associated requirements for product & company.
Employee qualifications
Moreover, we train your employees according to their tasks & responsibilities as:
We create your QM manual as a basic framework for your QM system.
Together we prepare the technical documentation for your audit.
We support you with our offer of interim management.
We are happy to be there for you
Meet up with us:
In the office or online – or send us an email whenever you want.
We look forward to meeting you!
+49 331 600 87 640
+49 331 600 87 640
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